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Clinical Trials of New Drug Febuxostat Show Promise in Gout Treatment

by Medindia Content Team on  December 8, 2005 at 3:07 PM Drug News   - G J E 4
Clinical Trials of New Drug Febuxostat Show Promise in Gout Treatment
A new drug called febuxostat has been found to reduce plasma levels of uric acid more effectively in Gout than the currently used drug allopurinol. If the results of the clinical trial are successful, then it would mean the end of a 40 year search for successful treatment of Gout.
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Gout is characterized by accumulation and deposition of needle shaped uric acid crystals in the joints, thereby leading to inflammation and pain. Progressively, it leads to a condition called 'Gouty arthritis' and is associated by a significant reduction in joint mobility.

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The only existing standard treatment for Gout is administration of allopurinol, which reduces the levels of uric acid production by blocking certain key steps in uric acid synthesis. In addition, it also decreases the plasma levels of uric acid over a period of time.

The study was conducted amongst a group of 762 patients, diagnosed to suffer from Gout and is believed to be the largest clinical trial ever done on patients with Gout. The mechanism of action of Febuxostat is very similar to allopurinol.

The study participants were either given allopurinol or febuxostat (two different doses) as a form of treatment, the goal of which was to reduce plasma uric acid levels by as much as 6 mg/dl. Allopurinol treatment was taken by 21% of the members, followed by 53 and 62% who took 80 and 120mg of febuxostat respectively.

At the end of the study, it was found that the new drug was more effective than allopurinol when used for more than a year, as revealed by statistical tests. However, a large number of patients were found to discontinue from the study due to the high incidence of adverse effects. The main site of drug metabolism is the liver which facilitates administration of the drug to patients with compromised kidney function as well.

The drug has not yet been approved by the U.S. Food and Drug Administration agency (FDA) for therapeutic use. More studies are clearly indicated to determine the long term clinical benefits of the new drug, taking into critical consideration the safety.
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